1. CELUI Services
Your Gateway to Pharma World
Fenil Shah
M.Pharm, PGDCR
Founder & CEO
Mob: +91 997 902 7203
Email: celuiregulatoryservices@gmail.com
Skype: celuiregulatoryservices1981
ww.celuiservices.com

2. - Providing consulting services to act as your Gateway to
Pharma World
- Team of Industry experience people worked in India’s top
pharmaceutical companies for 15 + years in regulated,
semi regulated and non regulated markets
• Zydus cadila
• Intas Pharmaceuticals
• Dr. Reddy’s laboratories
• Cadila Pharmaceuticals
- Committed to provide quality services in cost effective
manner
- Customized processes as per clients client requirements
About us

3. Services offered
- Regulatory affairs
- Pharmacovigilance
- Global liaison
- Contract manufacturing
- Patent & trademark registration
- Translation
- Technology transfer & dosing device
development

4. Regulatory Affairs
- Support in product development
- Preparation of regulatory strategy
- Dossier writing, compilation (CTD, EU CTD,
ANDA, ACTD, NeeS) & review
- Dossier publishing in eCTD
- Deficiency response from health agency & client
- Preparation of SmPC, Labelling, Leaflet
- Review of Assessment report from Health Agency
against dossier approval
- Variation or supplement filling as per country
specific guidance

5. Pharmacovigilance
Benefit/Risk Reports
• PADER (Periodic adverse drug experience report)
• PBRER (Periodic Benefit Risk Evaluation Report)
• RMP (Risk management plans)
• REMS (Risk Evaluation and Mitigation Strategies)
• Safety update reports
• Annual Safety Report/ Updates
Safety Processing
• Literature review
• ICSR processing
• MedWatch Preparation
Detailed description of the Pharmacovigilance System (DDPS)/
Pharmacovigilance Summary Master File
Safety data exchange agreement
Pharmacovigilance management plan

6. Global liaison &
Contract manufacturing
- We have contracts with world class
manufacturing facility
- All therapeutic class & dosage form available
- Accredited – WHO GMP, EU GMP, African
countries GMP
- CE marked, US DMF filled - pre-filled
syringes

7. Patent & Trademark registration
- Patent search, drafting, filling
- Trademark search, filling, registration
- Copyrights filling, registration
- Design search, filling, registration

8. Technology transfer & dosing
device development
- Technology transfer for API & finished product
in all dosage forms
- Experience technical industry people for
transfer
- Unique dosing device development as per
client requirement
- Single dose or multi dose device development

9. Thank You !
Contact us
Mob: +91 997 902 7203
Email: celuiregulatoryservices@gmail.com
Skype: celuiregulatoryservices1981
www.celuiservices.com